Lefamulin Medicine 13 December 2018 Extended indication Pneumonia, community-acquired; moderate to severe, including atypical pneumonia Therapeutic value Possible equal value Total cost Registration phase Clinical trials Product Active substance Lefamulin Domain Infectious diseases Reason of inclusion New medicine (specialité) Main indication Bacterial infections Extended indication Pneumonia, community-acquired; moderate to severe, including atypical pneumonia Current proprietary name Already available biosimilars / generics Proprietary name Manufacturer Nabriva Portfolio holder Mechanism of action Antibiotic Route of administration Oral Therapeutical formulation Unknown Budgetting framework Extramural (GVS) Centre of expertise Additional remarks pleuromutilin antibiotic, interferes with bacterial protein synthesis via a specific interaction with the 23S rRNA of the 50S bacterial ribosome subunit Registration Registration route Centralised (EMA) Type of trajectory Unknown Particularity Unknown ATMP Unknown Submission date 2019 Expected Registration 2020 Orphan drug No Registration phase Clinical trials Reimbursement Medicine sluice Additional remarks Therapeutic value Current treatment options moxifloxacine Therapeutic value Possible equal value This assessment does not indicate any potential inclusion in the package. Substantiation Lefamulin in klinische CAP trials is non-inferieur tov moxifloxacine. Echter, moxifloxacine is niet eerste keus voor CAP in Nederland. Duration of treatment Average 5 Not found Frequency of administration 2 times a day Dosage per administration 150 mg References LEAP1/2. Veve M. Rev Therapeutics 2018. Additional remarks Leap2 laat behandelduur van 5 dagen zien Expected patient volume per year Patient volume Market share is generally not included unless otherwise stated. Maximum patient volume for sluice References Additional remarks Beperkt aantal patiënten in Nederland. Expected cost per patient per year Cost References Additional remarks Potential total cost per year Total cost Total cost for sluice Additional remarks Off label use Off label use Unknown Indications off label use References Additional remarks Indication extension Indication extensions No Indication extensions References Additional remarks Other information Additional remarks